MAUDE Adverse Event Report: ARTHREX, INC. DEPTH GUIDE, MINI; GAUGE, DEPTH

Model Number	DEPTH GUIDE, MINI
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the top part of the depth guide fell off when the surgeon went to measure the drill hole for an implant.The tip was removed from the patient and the distal radius fracture case was completed.
Additional Manufacturer Narrative
Complaint confirmed, the tip was found to be detached from the inner component.Evaluation revealed the weld broke but the tip itself is whole.The tip was also found to be bent.A likely cause of the event is prying/leveraging the device during use.
Additional Manufacturer Narrative
Complaint confirmed, the tip was found to be detached from the inner component.Evaluation revealed the weld broke but the tip itself is whole.The tip was also found to be bent.A likely cause of the event is prying/leveraging the device during use.

• Brand Name: DEPTH GUIDE, MINI
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11648182
• Report Number: 1220246-2021-02878
• Device Sequence Number: 14508011
• Product Code: HTJ
• UDI-Device Identifier: 00888867007727
• UDI-Public: 00888867007727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DEPTH GUIDE, MINI
• Device Catalogue Number: AR-13120G-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021; 03/23/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 07/09/2021; 07/12/2021
• Patient Sequence Number: 1